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April 2009


Connecticut Emerging As Stem Cell Power
Stem Cell Research Vital Driver of CT Bioscience
CellDesign Presents at CURE/Yale BioHaven
CURE Member News Digest

CURE Member News Digest

454 Life Sciences (Branford)  A study published online  in Science reports that researchers have discovered a group of rare variants in a disease-associated gene that appear to lower the risk of developing type 1 diabetes (T1D). The study, conducted by scientists at the Wellcome Trust/JDRF Diabetes and Inflammation Laboratory at the University of Cambridge, used deep sequencing with the Genome Sequencer FLX system from 454 Life Sciences to re-sequence ten candidate genes including those previously identified by genome-wide associated studies (GWAS) of T1D.

In a statement, Michael Kishbauch, President and CEO of Achillion Pharmaceuticals, Inc. (New Haven), said: "The coming year is a potential break-out period for Achillion, as we expect to advance both of our lead programs for treating hepatitis C into the clinic. With ACH-1095 ... we believe we have the potential for a first-in-class NS4A antagonist that has been shown to work in combination with other therapies in development. With ACH-1625, we believe we have the potential for a best-in-class HCV protease inhibitor, given the compound's safety and pharmacokinetics. We believe that having both potential first-in-class and best-in-class therapies in HCV will provide us with a significant advantage, as HCV is a disease in which combination therapies are expected to become the standard of care."

Alexion Pharmaceuticals (Cheshire) announced that the Australian Government's Therapeutic Goods Administration has approved the use of Soliris® (eculizumab) for the treatment of all patients in Australia with paroxysmal nocturnal hemoglobinuria (PNH), a rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris® is the first therapy approved in Australia for the treatment of PNH.

Boehringer Ingelheim (Ingelheim, Germany/Danbury) announced that the last patient has completed treatment in the Phase 3 Randomized Evaluation of Long term Anticoagulant therapy (RE-LY®) study. This study compared the long-term efficacy and safety of the oral direct thrombin inhibitor dabigatran etexilate with the current standard therapy, warfarin, for the prevention of stroke and non-CNS systemic embolism in patients with atrial fibrillation. Dabigatran etexilate is an oral anticoagulant in Phase III development for stroke prevention in AF, as well as several other therapeutic areas. 

Bristol-Myers Squibb Company (New York/Wallingford) announced findings from an investigational study that demonstrated that, for patients with atrial fibrillation who were at increased risk for stroke and could not take an oral anticoagulant (OAC) medication, taking Plavix® (clopidogrel bisulfate) in addition to aspirin significantly reduced major vascular events by 11% over aspirin alone, at a median of 3.6 years of follow-up (6.8% vs. 7.6% per year, p=0.01). The greatest benefit was seen in the reduction of stroke, by 28% (2.4% vs. 3.3% per year, p<0.001), which is the primary goal of physicians treating patients with atrial fibrillation.

CellDesign Inc. (New Haven) signed an agreement with Stemgent to market CellDesign's AdipoDesign Starter Kit and AdipoDesign MaxiKit, which enable researchers to grow and study adipocytes from adipogenic progenitor cells. The AdipoDesign Starter Kit and AdipoDesign Maxi Kit comprise committed human adipogenic progenitor cells as well as recovery, maintenance, and differentiation media, and allow the researcher to produce functional human adipocytes in two weeks. With applications in the fields of drug discovery, basic and applied research, toxicity testing, high throughput screens, and regenerative medicine, the study and use of adipocytes derived from these kits has the potential to have a significant impact, CellDesign says.

Connecticut Innovations (Rocky Hill) announced that it has made an investment of $515,000 in Helix Therapeutics LLC (Helix) of New Haven, Conn., through its Eli Whitney Fund. This investment is part of a $965,000 round also involving LaunchCapital, individual investors, and a capital line of credit from Webster Bank. Helix is the first company to receive assistance through CI’s Pre-Seed Support Services Program and then go on to qualify for investment through the Eli Whitney Fund. This latest investment in Helix represents CI’s fourteenth investment in early-stage Connecticut technology companies since July 2008.

CuraGen Corporation (Branford) named John H. Forsgren to the newly created position of Executive Chairman of the Board. Mr. Forsgren has previously served as chief financial officer of several large public companies. He currently serves on the boards of The Phoenix Companies, Port Townsend Paper Company, and Trident Resources. He has served on the CuraGen board for seven years and is currently Chairman of the Audit Committee.

Cary Passik, MD, chief of cardiothoracic surgery at Danbury Hospital (Danbury) recently performed a double mammary coronary artery bypass. The complex procedure involves the use of arteries rather than veins to restore blood flow to the heart—a technique that yields improved long-term results and reduces the risk of needing a second bypass operation or angioplasty in the future, the hospital says.

Gualberto Ruaño, M.D., Ph.D. of Genomas Inc. (Hartford) was inducted into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows at a ceremony in Washington, DC at the National Academy of Sciences. Recipients of this honor are chosen for exceptional leadership and achievements in medical and biological engineering.

GlaxoSmithKline (Research Triangle Park, NC) has entered into a co-promotion agreement with Shire plc for Vyvanse®, to help improve the recognition and treatment of adult Attention Deficit Hyperactivity Disorder (ADHD). This 3-year agreement covers the United States only and will add a product to the GSK Neurosciences portfolio.

Hartford Hospital (Hartford) has appointed Donna M. Handley as Vice President of its Cancer Program. Ms. Handley joins Hartford Hospital from St. John Hospital and Medical Center in Detroit, where she served as Vice President of Clinical Services. She provided leadership for eight clinical areas, including oncology, surgery, cardiovascular care, anesthesia and imaging. Simultaneously, she was also the Executive Sponsor for St. John Health’s Oncology Clinical Network, for which she directed and led the health system’s oncology care.

Helix Therapeutics LLC (Guilford) received an investment of $515,000 from Connecticut Innovations (see above).

Commenting on 2008 results, Vincent Fert, CEO of Ipsogen (Marseille, France/New Haven), said: "Ipsogen has recorded a very good year, with revenue beating expectations, cash spending kept under control and numerous operational successes. Given our 2008 figures and the dynamism of the market segment on which we operate, we are serenely heading into 2009, a year that will see further substantial growth in activity."

Cordis Corporation, a company of Johnson & Johnson (New Brunswick, NJ), celebrated its 50th anniversary in March. "Our vision at Cordis is to transform cardiovascular care, a field in which incredible progress has been made, but one in which so much more remains to be done," said Seth Fischer, Worldwide Franchise Chairman.

MannKind Corporation (Valencia, CA/Danbury) has submitted a New Drug Application to the U.S. Food and Drug Administration  requesting approval of AFRESA® (insulin monomer human [rDNA origin]) Inhalation Powder and the AFRESA® Inhaler for the treatment of adults with type 1 or type 2 diabetes mellitus for the control of hyperglycemia. AFRESA® is an ultra rapid-acting insulin. It is a drug-device combination product, consisting of AFRESA® Inhalation Powder pre-metered into single unit dose cartridges and the AFRESA® Inhaler as the delivery device for oral inhalation. However, the feature that distinguishes AFRESA® from all other insulin products is not the route of administration it is the pharmacokinetic profile, the company says. The large surface area of the lung provides unique access to the circulatory system. The pH-sensitive AFRESA® particles immediately dissolve upon contact with the lung surface, releasing insulin monomers that rapidly enter the bloodstream. AFRESA® achieves peak insulin levels within 12-14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals, but which is absent or impaired in patients with diabetes.

Marinus Pharmaceuticals, Inc. (Branford) announced that it met its primary endpoint for its Phase 2 clinical trial investigating the safety and efficacy of ganaxolone as adjunctive therapy in adults with partial onset seizures, a type of epilepsy. In this trial, ganaxolone demonstrated a statistically significant reduction in seizures versus placebo. Efficacy was seen in the first week of dosing. Ganaxolone was also found to be safe and well-tolerated in this population adding to the safety database of more than 950 subjects.

NanoViricides, Inc. (West Haven) signed a material transfer agreement with a major pharmaceutical company. It entails evaluation of one of NanViricides' drug candidates by an independent consultant chosen by the pharma company. "This agreement is the first step towards a potential licensing agreement," said Eugene Seymour, MD, MPH, CEO of Nanoviricides, adding, "It clearly signals that our technology is now attracting serious attention."

Commenting on 2008 results, Stephen R. Davis, presidnet and CEO of Neurogen Corporation (Branford), said: "In 2008, we dramatically restructured and refocused Neurogen to concentrate on the advancement of our clinical programs. We were pleased to report positive results with aplindore in both our Parkinson’s disease and our Restless Legs Syndrome Phase 2a studies while simultaneously reducing our cost basis and monetizing non-core assets. In each study, aplindore demonstrated robust efficacy and very promising tolerability profiles, consistent with our target of improving on the side effects of currently available drugs for each of these disorders. In 2009, we will continue to carefully invest our capital as we move forward with the screening and enrollment of patients in the Phase 2b studies in Parkinson’s disease and RLS, and simultaneously pursue partnering opportunities."

Pfizer Inc. (New York, NY/Groton/New London) announced the results of a study that found that 47 percent of smokers with a history of cardiovascular disease who took CHANTIX/CHAMPIX® (varenicline) were able to quit smoking and remain abstinent during the last four weeks of treatment (weeks 9-12) compared with just 13.9 percent of those given placebo.

Pharmaceutical Research and Manufacturers of America (PhRMA) (Washington, DC) issued a statement regarding health reform: "[A]ll Americans should be able to access high-quality and affordable healthcare coverage ... It’s widely recognized that the health reform process thus far has been built on the promise of bipartisanship so that we can build consensus around ideas that can help assure that all Americans can access high-quality and affordable healthcare coverage. To help keep the bipartisanship spirit alive and also help Congress achieve a final product that the American people are collectively supportive of, the House and Senate should seek healthcare reform through regular order ... [I]f we all continue to work together and have constructive dialogue to help find common ground, this can surely happen."

Svigals + Partners, LLP (New Haven) has elevated two senior level employees – Christopher Bockstael and Walter Chabla – from the position of project manager to associate principal. Bockstael brings 15 years of architecture design and project management experience to his new position. Since joining Svigals + Partners in early 2004, he has overseen more than 50 projects, including multiple programs at Yale. Chabla is a seasoned project manager with more than 30 years of domestic and international architectural design and construction administration experience. He joined Svigals + Partners in late 2006 and has since overseen a majority of the firm’s elementary school, high school and educational revitalization projects, including New Haven’s John S. Martinez School.

Following is recent news from The University of Connecticut (Storrs) and the University of Connecticut Health Center (Farmington).

The cost of ‘defensive’ medicine – tests, procedures, referrals, hospitalizations, or prescriptions ordered by physicians fearful of lawsuits – is huge and widespread, according to a study by the Massachusetts Medical Society and UConn Health Center researcher Robert Aseltine Jr. more

Akiko Nishiyama, associate professor of physiology and neurobiology is gaining recognition for her research on cells in the brain. Her invited lead review paper in the January 2009 issue of Nature Reviews Neuroscience covers the state of research into NG2 cells, a type of glial cell in the central nervous system that she began studying more than 20 years ago. Once described as housekeeping cells that support neurons and remove debris, glial cells are now thought to have a much more active role in the brain and spinal cord. more

Liisa Kuhn’s biomaterials engineering research could ultimately lead to tissue regeneration or a new cancer treatment, perhaps even a cure. Her work may not be used in the clinic quite yet, but its promise impressed the Connecticut Technology Council enough to name her a 2009 Women of Innovation Award winner. Kuhn, an assistant professor in the Center for Biomaterials and Regenerative Medicine at the UConn Health Center, was one of 10 winners among 52 finalists, all considered “innovators, role models, and leaders in the technology, science, and engineering fields” by the Connecticut Technology Council, the state’s industry association for the technology sector. more

The growing commercial use of nano particles and nano-sized devices just billionths of a meter in length has raised concerns about the potential health and environmental implications of such products. Recently, Christopher Perkins, laboratory director at the Center for Environmental Sciences and Engineering, and Sylvain De Guise, an associate professor of pathobiology in the College of Agriculture and Natural Resources, discovered that popular disinfectants using nanosilver particles could affect some people’s health. more

In a report to the General Assembly, the Connecticut Academy of Science and Engineering has recommended that the General Assembly approve the clinical partnership being proposed by the UConn Health Center and Hartford Healthcare Corp., the parent company of Hartford Hospital. The partnership would form a new corporation called University Hospital Inc. more

A study led by nutritional scientist Richard Bruno has found that green tea can help mitigate the impact of nonalcoholic fatty liver disease. Bruno, an assistant professor of nutritional sciences in the College of Agriculture and Natural Resources, and his research team have found that the daily ingestion of green tea blocks the amount of fat stored in the livers of obese mice that otherwise develop severe fatty liver disease; improves liver function; and reverses declines in antioxidant defenses in the liver. more

The UConn School of Pharmacy has received a $781,000 grant to build an electronic medication information exchange for the state that proponents hope will be a major step forward in improving the delivery of health care in Connecticut. Pharmacy faculty, the Connecticut Pharmacists Association, and a newly-created network of Connecticut pharmacists will use the funds to develop comprehensive medication profiles for 1,000 Connecticut Medicaid patients, and medication therapy management and adherence pilot programs for 200 Medicaid patients. more

The nation’s health care system will face significant challenges in the coming decades, as the number of individuals living with cancer rises dramatically along with the aging of the baby boomers, according to Keith Bellizzi, assistant professor of human development and family studies in UConn's  College of Liberal Arts and Sciences. Bellizzi recently served as guest editor for a special supplement of the journal Cancer that addressed the topic. more

Following is recent news from Yale University and the Yale School of Medicine (New Haven).

Yale researchers have filled in a missing gap on the molecular road map of Alzheimer’s disease. In the Feb. 26 issue of the journal Nature, the Yale team reports that cellular prion proteins trigger the process by which amyloid-beta peptides block brain function in Alzheimer’s patients. "It has been a black box," said Stephen M. Strittmatter, senior author of the study and the Vincent Coates Professor of Neurology and director of Cellular Neuroscience, Neurodegeneration and Repair at the Yale School of Medicine.  "We have known that amyloid-beta is bad for the brain, but we have not known exactly how amyloid-beta does bad things to neurons."

After an extensive national search, Thomas J. Lynch, Jr., MD, has been named director of Yale Cancer Center and physician-in-chief of the new Smilow Cancer Hospital at Yale-New Haven, which will open in October 2009. His appointment is effective April 1, 2009. Dr. Lynch, professor of medicine at Harvard Medical School, is chief of hematology/oncology at Massachusetts General Hospital (MGH) Cancer Center. A lung cancer expert, he is director of the Center for Thoracic Cancers at MGH and director of medical oncology at the MGH Thoracic Oncology Center.

Scientists used to think most of the exchange of information between cells was conducted at the surface, where cell receptors receive signals from other cells. Now Yale researchers report in the March 20 issue of the journal Cell how a switching station beneath the cell surface is crucial to processing signals from outside the cell. They also describe a key molecular switch that terminates signaling from this station. The findings portray a much more "complex and fluid system of cellular information processing than previously envisioned," said Derek K. Toomre, assistant professor of cell biology at Yale and co-author of the study.

Yale scientists have found a way to study within a living organism the wonders of micro-RNAs – tiny bits of RNA that act like a sculptor and shape the activity of hundreds of genes. The work is reported in the March 1 edition of the journal Genes & Development. Antonio J. Giraldez, the Lois and Franklin Top Assistant Professor in the genetics department of the Yale School of Medicine, is senior author of the study.

Two-year-olds with autism lack an important building block of social interaction that prompts newborn babies to pay attention to other people. Instead, these children pay attention to physical relationships between movement and sound and miss critical social information. Researchers at the Yale School of Medicine report their results in the March 29 online issue of Nature. Ami Klin, director of the Autism Program at Yale and the Harris Associate Professor of Child Psychology at the Yale Child Study Center, said, "Rather than attending to human biological motion, and the social cues in that motion, children with autism were very sensitive to non-social information: to synchronies between sounds and motion in what they were watching." 

The helpless behavior that is commonly linked to depression and post-traumatic stress disorder is preceded by stress-related losses of synapses — microscopic connections between brain cells — in the brain’s hippocampal region, researchers at Yale School of Medicine report in the March 1 issue of Biological Psychiatry. "In clinical practice, the main problem with antidepressants is that they require weeks to exert their effect," said lead scientist on the project Tibor Hajszan, M.D., associate research scientist in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine. "Because there are ways to restore these lost hippocampal synapses in as little as hours or even minutes, our laboratory is currently testing rapid-acting antidepressants that could provide immediate relief from depressive symptoms."

Yale researchers investigating the genetic causes of blood pressure variation have identified a previously undescribed syndrome associated with seizures, a lack of coordination, developmental delay and hearing loss. "Our ability to unequivocally and rapidly define new syndromes and their underlying disease genes has progressed dramatically in recent years," said Richard Lifton, chair of the Department of Genetics at the Yale School of Medicine and senior author of the study, published in Proceedings of the National Academy of Sciences.

Elderly women who suffer a first “mini-stroke” are less likely than men of the same age to be readmitted to a hospital, according to a study led by the Yale School of Public Health.  The paper appears in the online version of Stroke, the journal of the American Heart Association. While additional research is needed to better understand the reasons for the gender-related difference in health outcomes, the findings could help to improve care and outcomes for both men and women, said Judith H. Lichtman, an associate professor in the division of Chronic Disease Epidemiology and the study’s lead author.

Research from Yale School of Medicine researchers that links changes brought on by anger or other strong emotions to future arrhythmias and sudden cardiac arrests, which are blamed for 400,000 deaths annually. The study was led by Rachel Lampert, M.D., associate professor of medicine at Yale School of Medicine, and published in the Journal of the American College of Cardiology.

Younger people with strong negative stereotypes about the elderly are more likely to experience strokes, heart attacks and other heart problems when they grow old, a researcher at the Yale School of Public Health has found. "We found that the age stereotypes, which tend to be acquired in childhood and young adulthood, and carried over into old age, seem to have far-reaching effects," said Becca R. Levy, associate professor of epidemiology and psychology and the study’s lead author. The study appears in the March issue of the journal Psychological Science.

Yale scientists and colleagues at Boston University School of Medicine and the University of Connecticut have discovered genetic variants that increase the risk of paranoia in cocaine addicts and also seem to affect risk for cocaine dependence itself, although most of the molecular culprits that make some people more susceptible to cocaine dependence remain elusive. "We feel that these findings are of great interest because of the novelty of the physiological pathway involved," said Joel Gelernter, M.D., professor of psychiatry, genetics, and neurobiology, and director of the Division of Human Genetics in Psychiatry at the Yale University School of Medicine.

In a study that gives insight into the depth of stigmatization against overweight and obese people, a Yale University-led team of researchers found weight bias even among those studying to be dieticians. The research appears in the March issue of the Journal of the American Dietetic Association. "These stereotypes are similar to negative attitudes reported by a range of health-care providers," write authors Rebecca Puhl and Chelsea Heuer of the Rudd Center for Food Policy and Obesity at Yale and Christopher Wharton of Arizona State University.

New research has found that an individual’s personal beliefs about the causes of weight problems are a reliable indicator of whether he or she will support public policies designed to combat the problem. "Our results suggest that viewing obesity as a matter of personal responsibility lowers public tolerance for government regulation, while emphasizing the social and environmental causes of obesity has the potential to drive up public support," said Colleen L. Barry, Ph.D., assistant professor in the division of Health Policy and Administration, and the study’s lead author.

More prominent displays may be needed to help increase consumer awareness of nutritional information in fast food restaurants, according to an observational study from Yale University that appears in the May issue of the American Journal of Public Health. "It is notoriously difficult to estimate the calories in fast food meals," said Kelly Brownell, director of the Rudd Center for Food Policy and Obesity at Yale and an author of the study. "Polls show that consumers want the information and this study shows how they need it in a more prominent and visible place – right on the menus and menu boards."

A popular smoking cessation drug, Pfizer's CHAMPIX®, dramatically reduced the amount a heavy drinker will consume, a new Yale School of Medicine study has found. "We anticipate that the results of this preliminary study will trigger clinical trials of varenicline [the drug involved] as a primary treatment for alcohol use disorders, and as a potential dual treatment for alcohol and tobacco use disorders," said Sherry McKee, associate professor of psychiatry at the Yale School of Medicine and lead author of the study.

Nearly $7 million in combined grants have been awarded to a researcher at the Yale School of Public Health to examine the effects of exercise on two types of cancer unique to women. Melinda L. Irwin, Ph.D., associate professor in the division of Chronic Disease Epidemiology received the funding from the National Cancer Institute (NCI) to study whether physical activity can affect ovarian and breast cancer prognosis and survivorship.

In an effort to accelerate improvements in the effectiveness and efficiency of healthcare in developing nations around the world, Yale University has launched the Global Health Leadership Institute.  "Sharing Yale’s broad expertise with government health care leaders and academic colleagues in the developing world can have a significant impact on their efforts to improve care," said President Richard C. Levin. "Combined with the education at Yale of students seeking to be the next global health leaders, this initiative will add to the University’s international influence on major health challenges."

For more member news, see the March 2009 issue of CURE News

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